BONESUPPORT’s FDA notification: Approval on DeNovo pathway for CERAMENT G will require additional data and clarifications
Lund, Sweden, 14:30 CET, 27 02 21 –BONESUPPORT ™, a leading company active in orthobiology for the treatment of skeletal injuries, today announced that the company has received a notification from the US Food and Drug Administration (FDA) that the company’s DeNovo application for CERAMENT G for bone infections can not be concluded without additional data and clarifications. "We had obviously hoped to launch CERAMENT G in the US, for the indication bone infections, during the spring 2021, but the approval process with CERAMENT G being “the first of its kind”, will require additional